Federal Register
Latest Federal Register Notices
FDA Review has posted the Federal Register notices for the week ending 11/22/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Endo BLA Accepted for Cellulite Therapy
FDA accepts for review an Endo International BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the buttocks.
Human Drugs
Trump Extends FDA, Other Funding for 30 Days
President Trump signs a short-term continuing resolution that funds FDA and other agencies at FY 2019 funding rates through 12/20.
Human Drugs
SK Life Sciences Seizure Drug Approved
FDA approves a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults.
Medical Devices
Panel Summary on Amalgam, Other Metal Devices
FDA posts a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting, which recommen...
Federal Register
Info Collection on FOIA Identity Form
Federal Register notice: FDA seeks comments on an information collection extension for Certification of Identity; Form FDA 3975.
Federal Register
Info Collection for Device Shortage Data System
Federal Register notice: FDA sends to OMB an information collection for Medical Devices; Shortages Data Collection System.
Human Drugs
Justice Hits Foundation Conspiracy with Drug Firms
The U.S. Justice Department announces that a Florida foundation has agreed to pay $4 million to resolve allegations that it violated the False Claims ...
CBER Raps RichSource for Cell Therapy Claims
CBER Office of Compliance and Biologics Quality issues RichSource Stem Cells an untitled letter over promotional statements on its Web site for cell t...
